Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings (IRAF-WORKUP)

Insel Gruppe AG, University Hospital Bern

Status and phase: Enrolling; Phase 4

Conditions: Suspect Renal and Adrenal Imaging Findings

Treatments: Drug: Gadobutrol (Gadovist/Gadavist); Drug: Gadopiclenol

Study type: Interventional

Funder types: Other

Identifiers

NCT07040865

BASEC 2025-00253 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the effects of the contrast agent Gadopiclenol with those of the standard contrast agent Gadobutrol.

The main question of this study is :

Does gadopiclenol offer diagnostic properties that are equally effective as those of gadobutrol?

Participants will be:

• randomly assigned to one of two groups: the experimental group, which receives gadopiclenol, or the control group, which receives gadobutrol. Each participant is informed of their group allocation prior to the magnetic resonance imaging (MRI) scan.
• invited for a single MRI appointment lasting approximately 60 minutes

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed informed consent
• age ≥18 years
• compatibility with magnetic resonance imaging
• planned workup of kidney incidental finding or adrenal incidental findings (or both)
• body mass index (BMI) < 31 kg/m2

Exclusion criteria

• patients with implants that might affect imaging parameters in the region under investigation, as judged by the principal investigator
• vulnerable individuals
• claustrophobic individuals
• individuals that are cognitively impaired or unable to understand the language
• pregnant or breastfeeding patients

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Gadobutrol (control)

Active Comparator group

Description:

0.1 mmol/kg gadobutrol will be injected intravenously.

Treatment:

Drug: Gadobutrol (Gadovist/Gadavist)

Gadopiclenol

Experimental group

Description:

0.05 mmol/kg gadopiclenol will be injected intravenously.

Treatment:

Drug: Gadopiclenol